Description
Latin name
DESLORATADINE
Release form
tablets coated
packaging 10 pcs – blister packagings (1) – packs of cardboard.
Pharmacological action
Farmgroup: antiallergic agent – H1-histamine receptor blocker.
Pharmaceutical action:
Blocker of H1-histamine receptors (long-acting). It is the primary active metabolite of loratadine.
Suppresses the release of histamine and leukotriene C4 from mast cells.
Prevents development and facilitates the course of allergic reactions.
is anti-allergic,
Intensively metabolized in the liver by hydroxylation to form 3-OH-desloratadine coupled to glucuronide. Only a small portion of the oral dose is excreted by the kidneys (When using desloratadine at a dose of 5-20 mg once a day for 14 days, no signs of clinically significant cumulation were detected.
Indications
Seasonal and perennial allergic rhinitis, chronic idiopathic urticaria.
Contraindications
Hypersensitivity, pregnancy, lactation, children (up to 1 year), children (up to 12 years) for tablet forms.
For syrup (optional, due to the presence of sucrose and sorbitol in the composition): hereditary fructose intolerance, impaired glucose / galactose absorption, or sucrose / isomaltose deficiency.
Caution. Severe renal failure.
Use during pregnancy and lactation
Use of the drug during pregnancy is contraindicated in the absence of clinical data on the safety of its use during pregnancy.
Desloratadine is excreted in breast milk, so the use of the drug during breastfeeding is contraindicated.
Composition
Tablets, film-coated blue, round, biconvex in cross section, the core is white or almost white.
1 tab.
desloratadine 5 mg
Excipients:
calcium hydrogen phosphate dihydrate – 53 mg,
microcrystalline cellulose – 27.5 mg,
corn starch – 11 mg,
talcum – 2.5 mg,
magnesium 1 mg.
Composition of the film coat:
dry mix for film coating (polyvinyl alcohol – 40%, titanium dioxide – 22.1%, macrahol 3350 (polyethylene glycol 3350) – 20.2%, talc – 14.8%, aluminum varnish based on the dye indigo carmine – 2.8%, iron yellow oxide (iron oxide) – 0.1%) – 3 mg.
Dosage and Administration
Inside. The tablet should be swallowed whole, without chewing, washed down with a small amount of water.
It is advisable to take the drug at the same time of the day, regardless of the time you take it.
Adults and adolescents from 12 years old – 1 tablet (5 mg) once a day. The duration of therapy depends on the duration of symptoms.
In seasonal (intermittent) allergic rhinitis (the presence of symptoms lasting less than 4 days a week or their total duration less than 4 weeks a year) and urticaria, it is necessary to evaluate the course of the disease. If the symptoms disappear, the drug should be discontinued, if the symptoms reappear, the drug should be resumed.
In case of year-round (persistent) allergic rhinitis (the presence of symptoms lasting more than 4 days a week or their total duration more than 4 weeks a year), treatment can continue throughout the entire period of exposure to allergens.
To determine the duration of drug therapy, you should consult your doctor.
Rare: dizziness, somnolence, tachycardia, palpitations, abdominal pain, dyspepsia (including nausea, vomiting, diarrhea), hyperbilirubinemia, elevated liver enzymes, allergic reactions (rash, pruritus, urticaria, angioneurotic swelling, anaphylactic shock).
In children under 2 years of age (the frequency is slightly higher than when taking a placebo): diarrhea, hyperthermia, insomnia.
In 2 11 years of age, the incidence of side effects is comparable to placebo.
In adults and children over 12 years of age (the frequency is slightly higher than when taking a placebo): fatigue, dry mouth, headache, drowsiness (the incidence is comparable to placebo).
Drug Interaction
Interaction with other medicinal products has not been detected in studies with azithromycin, ketoconazole. erythromycin, fluoxetine and cimetidine.
Eating does not affect the effectiveness of the drug.
Desloratadine does not increase the effect of alcohol on the central nervous system.
Overdose
Symptoms
Taking a dose in excess of the recommended 5 times did not lead to any symptoms. The daily use of desloratadine in adults and adolescents at doses up to 20 mg for 14 days was not accompanied by statistically or clinically significant changes from the cardiovascular system. The use of desloratadine at a dose of 45 mg per day (9 times higher than recommended) for 10 days did not cause QT prolongation and was not accompanied by serious side effects.
Treatment
In case of accidental intake of a large amount of the drug, it is necessary to consult a doctor immediately. Gastric lavage, activated charcoal is recommended, symptomatic therapy if necessary. Desloratadine is not excreted in hemodialysis, the efficacy of ipersonsial dialysis has not been established.
Storage conditions
In the dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.
Expiration
Expiration is 3 years.
Deystvuyuschee substance
desloratadine
dosage form
dosage form
tablets
Vertex, Russia
